70 FR 67 pgs. 18032-18034 - Agency Information Collection Activities; Proposed Collection;Comment Request; Experimental Study of Carbohydrate Content Claims on FoodLabels
Type: NOTICEVolume: 70Number: 67Pages: 18032 - 18034
Docket number: [Docket No. 2005N-0120]
FR document: [FR Doc. 05-7026 Filed 4-7-05; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0120]
Agency Information Collection Activities; Proposed Collection;Comment Request; Experimental Study of Carbohydrate Content Claims on FoodLabels
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) isannouncing an opportunity for public comment on the proposed collection ofcertain information by the agency. Under the Paperwork Reduction Act of1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection ofinformation and to allow 60 days for public comment in response to thenotice. This notice solicits comments on a consumer experimental study ofcarbohydrate content claims on food labels.
DATES:
Submit written or electronic comments on thecollection of information by June 7, 2005.
ADDRESSES:
Submit electronic comments to http://www.fda.gov/dockets/ecomments . Submit written commentson the collection of information to the Division of Dockets Management(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,Rockville, MD 20852. All comments should be identified with the docketnumber found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Officeof Management Programs (HFA-250), Food and Drug Administration, 5600Fishers Lane, Rockville, MD 20857,301-827-1223.
SUPPLEMENTARY INFORMATION:
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtainapproval from the Office of Management and Budget (OMB) for each collectionof information they conduct or sponsor. "Collection ofinformation" is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) andincludes agency requests or requirements that members of the public submitreports, keep records, or provide information to a third party. Section3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federalagencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting thecollection to OMB for approval. To comply with this requirement, FDA ispublishing notice of the proposed collection of information set forth inthis document.
With respect to the following collection of information, FDA invitescomments on these topics: (1) Whether the proposed collection ofinformation is necessary for the proper performance of FDA's functions,including whether the information will have practical utility; (2) theaccuracy of FDA's estimate of the burden of the proposed collection ofinformation, including the validity of the methodology and assumptionsused; (3) ways to enhance the quality, utility, and clarity of theinformation to be collected; and (4) ways to minimize the burden of thecollection of information on respondents, including through the use ofautomated collection techniques, when appropriate, and other forms ofinformation technology.
Experimental Study of Carbohydrate Content Claims on Food Labels
The authority for FDA to collect the information for this experimentalstudy derives from the Commissioner of Food and Drugs' authority, asspecified in section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act(the act) (21 U.S.C. 393(d)(2)).
The Nutrition Labeling and Education Act of 1990 (Public Law101-535) amended the act. Section 403(r)(1)(A) of the act (21 U.S.C.343(r)(1)(A)) was added under these amendments. This section states that afood is misbranded if it is a food intended for human consumption which isoffered for sale and for which a claim is made on its label or labelingthat expressly or implicitly characterizes the level of any nutrient of thetype required to be declared as part of nutrition labeling, unless suchclaim uses terms defined in regulations by FDA under section 403(r)(2)(A)of the act.
In 1993, FDA published regulations that implemented the 1990 amendments.Among these regulations, § 101.13 (21 CFR 101.13) sets forthgeneral principles for nutrient content claims (see 56 FR 60421, November27, 1991, and 58 FR 2302, January 6, 1993). Other regulations in subpart Dof part 101 (21 CFR part 101, subpart D) define specific nutrient contentclaims, such as "free," "low,""reduced," "light," "good source,""high," and "more" for different nutrients andcalories, and identify several synonyms for each of the defined terms. Inaddition, § 101.69 establishes the procedures and requirementsfor petitioning the agency to authorize nutrient content claims.
The Food and Drug Administration Modernization Act of 1997 (Public Law105-115) amended section 403(r)(2) of the act by adding sections403(r)(2)(G) and (r)(2)(H) to permit nutrient content claims based onpublished authoritative statements by a scientific body when FDA isnotified of such claims in accordance with the requirements established inthese sections.
Current FDA regulations make no provision for the use of nutrientcontent claims that characterize the level of carbohydrate in foods becauseFDA has not defined, by regulation, terms for use in such claims. FDA hasbeen petitioned to amend existing food labeling regulations to define termsfor use in nutrient content claims characterizing the level of carbohydratein foods.
The purpose of this proposed data collection is to help enhance FDA'sunderstanding of consumer response to carbohydrate content claims on foodlabels. More specifically, this experimental study will help answer thefollowing research questions:
1. Does the presence of a given front panel carbohydrate content claimsuggest to consumers that the product is lower or higher in totalcarbohydrate, calories, and other nutrients (i.e., total fat, fiber, andprotein) than the same product without the claim or with a differentclaim?
2. Does the presence of a given front panel carbohydrate content claimsuggest to consumers who do not view the Nutrition Facts panel that thefood is healthier or otherwise more desirable than the same product withoutthe claim or with a different claim?
3. Does the presence of a front panel carbohydrate content claim suggestto consumers that the product is healthier than the same product without aclaim or with a different claim despite information to the contraryavailable on the Nutrition Facts panel?
4. Do disclosure statements help consumers to draw appropriateconclusions about products with carbohydrate content claims on the frontpanel?
The label claims that would be tested in the proposed study include"carb-free," "low carb," "x g netcarbs," "carbconscious," "good source ofcarb," and "excellent source of carb." The study wouldalso include control labels (labels not bearing a claim). Where relevant,this study would test carbohydrate content claims with and without thefollowing disclosure statements: (1) "see nutrition information forfat content," (2) "see nutrition information for sugarcontent," and (3) "not a low calorie food."
Participants would see mock food label images for one of three products:(1) A loaf of bread, (2) a can of soda, and (3) a frozen entrée.Three products were selected to understand whether consumer perception ofcarbohydrate content claims changes when the food is a traditionallyhigh-carbohydrate, ubiquitous staple (bread), a beverage (soda), or acomplete meal (frozen entrée).
Half of the participants would see only a front panel with acarbohydrate content claim or a control label not bearing a claim. Theother half of the participants would see both the front panel and the backpanel, which includes the Nutrition Facts information. In the NutritionFacts panel for the bread and frozen entrée, the calorie, fat, andfiber content would vary to create more and less healthful productprofiles. Total carbohydrate content would also vary. On the NutritionFacts panel for the soda, the sugar content, and therefore totalcarbohydrate content and calories, would vary.
The proposed experimental study would be conducted online via theInternet. The sample would be drawn from an existing consumer opinionpanel developed and maintained by the research firm Synovate. Synovate'sInternet panel consists of 600,000 households that have agreed toparticipate in research studies conducted through the Internet.
Panel members are recruited by a variety of means designed to reflectall segments of the population. They are required to have a computer withInternet access. Typical panel members receive three or four invitationsper month to participate in research projects. Periodically, Synovategives incentives of small monetary value to panel members for theirparticipation. Studies begin with an e-mailed invitation to the sampledrespondents.
For this proposed study, Synovate's Internet panel would be screened fordiet status. Twenty-five percent of the households in the Internet panel(150,000 households) are expected to respond to the screening questions.Based on information gathered from the screening process, a sample would bedrawn to allow for 2,500 participants in each of 4 groups: (1) Diabeticconsumers, (2) consumers who try to eat a diet low in carbohydrate (but whoare not diabetic), (3) consumers who try to eat a diet high incarbohydrate, and (4) consumers who are not part of any of the precedingthree groups. Assignment to a condition would be random within each of thefour groups of consumers. Of the members of the Internet panel who respondto the screening questions and are selected for the study (18,200 panelmembers), 55 percent (10,000 panel members) are expected to participate inthe experiment.
FDA estimates the burden of this collection of information asfollows:
| Activity | No. of Respondents | Annual Frequency per Response | Total Annual Responses | Hours per Response | Total Hours | ||||
|---|---|---|---|---|---|---|---|---|---|
| Cognitiveinterviews | 9 | 1 | 9 | 0.5 | 5 | ||||
| Pretest | 150 | 1 | 150 | 0.17 | 26 | ||||
| Screener | 150,000 | 1 | 150,000 | 0.01 | 1,500 | ||||
| Experiment | 10,000 | 1 | 10,000 | 0.12 | 1,200 | ||||
| Total | 2,731 | ||||||||
| 1 There are no capital costs or operating andmaintenance costs associated with this collection of information. | |||||||||
These estimates are based on FDA's experience with previous consumerstudies. The cognitive interviews are designed to ensure that thequestions are worded as clearly as possible to consumers. The cognitiveinterviews would take each respondent 30 minutes to complete. The pretestof the final questionnaire is designed to minimize potential problems inthe administration of the interviews. The pretest is predicted to takeeach respondent approximately 10 minutes to complete.
The screener would be sent via the Internet to the entire 600,000household Internet panel, of which 25 percent (150,000 households) arepredicted to respond. The brief screener is predicted to take eachrespondent 36 seconds to complete.
The experiment would be conducted with 10,000 panel members. Theexperiment is predicted to take each respondent approximately 7 minutes tocomplete.
Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7026 Filed 4-7-05; 8:45 am]
BILLING CODE 4160-01-S